Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme
NCT00075491 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2013-01-24
Summary
This randomized phase II trial is studying how well neoadjuvant and adjuvant fenretinide works compared to adjuvant fenretinide alone in treating patients who are undergoing surgical resection for recurrent glioblastoma multiforme. Chemotherapy drugs, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether neoadjuvant and adjuvant fenretinide is more effective than adjuvant fenretinide alone
Conditions
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Recurrent Adult Brain Tumor
Interventions
- DRUG
-
fenretinide
Given orally
- PROCEDURE
-
therapeutic conventional surgery
Undergo surgery
- OTHER
-
pharmacological study
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Vinay K. Puduvalli · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2005-03-31
Countries
- United States
Study Locations
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